Wednesday, July 9, 2014

Recently a family health crisis has caused a severe disruption in my life and made it impossible to continue to blog for the time being. I do hope to return to blogging at some point but right now I need to focus my attention and energy elsewhere. Please accept my apologies and understand that blogging will be light to non-existant for another month or two. If you follow me on Twitter you'll know when a new post is up.

We
were talking about the Ebola Virus outbreak in West Africa, which has been boiling
for several months now, when a colleague asked: “There are Ebola vaccines for
primates and mice, but not for humans. Why?” And, answered: “for the same
reasons that there has been a West Nile vaccine for horses for a decade, but
none for humans— partly regulatory hurdles, but more decisively the actions of
that ‘free marketplace’ that our governmental and corporate elites are so fond
of.”

I
replied, colleague, the Center for Disease Control has a limited budget. It is
obligated to allocate its resources in the most cost effective manner possible
– which means doing as much good as it can with the funds at its disposal – if
other initiatives generate more quality-adjusted life years (QUALYs) per dollar,
they have first call on the dollars. Normally, where health issues are
concerned, Congress appropriates funds whenever an agency can show that a
program will generate net benefits (expected additional QUALYs @ $400K each less
program cost – in this case the cost of developing and distributing a vaccine –
is greater than 0). Presumably, the CDC has not made such a representation with
respect to Ebola. As for West Nile Fever, the finding was negative (taking
account only of threats to Americans).

Decision
tree for vaccination program analysis

My
colleague replied: “The CDC’s evaluation concerns only the desirability of widespread
vaccination, and they’re probably right on that point. But this doesn’t
address the prior question of the non-existence of the human vaccine. I
continue to feel that the government should be in the business of developing
and manufacturing vaccines, and perhaps all pharmaceuticals.”

So
far as vaccines are concerned, I agree. But vaccines are a special category of
pharmaceuticals. Pharmaceuticals generally look like toll goods
(non-exhaustible but excludable). Vaccines look more like pure public goods. Left
to the private sector, they would almost certainly be undersupplied. For that
reason, most vaccine development is underwritten by public agencies. In some instances,
those agencies will not stop with research and development, but will also
guarantee sufficient purchases to pay for the testing needed to prove the
safety (to humans) and efficacy of new formulations, which the FDA requires
before it will grant regulatory approval for a prescribed use. In most cases,
however, the US government will underwrite these activities only where it is
deemed cost effective to do so. Consequently, your horse can get a jab for West
Nile virus, but you cannot. Moreover, you won’t be able to get one legally in
the US until the FDA is satisfied through clinical tests that the vaccine is
both safe and effective (unless, of course, you are a uniformed member of the
US military deploying abroad).

Note
that the legal requirements for the approval of new formulations (or the
application of existing formulations for new purposes) are not subject to any
kind of benefit cost test, but are very close to absolute fiat (although, under
special circumstances, the FDA can put a new formulation on a fast track aimed
at reducing testing costs; it can also weigh relative health risks, although it
does so very cautiously). Moreover, proving the efficacy and safety of a
vaccine is fraught with difficulties not encountered by other drugs. First,
they are supposed to be prophylactic. One doesn’t have a population of the
afflicted to test the formulation upon (using a nice neat double-blind
experimental design, with the test population randomly assigned to treatment
and control groups). Consequently, testing for efficacy under normal
circumstances requires large sample sizes and monitoring over a wide area for a
long period, which greatly increases the cost of approval and the return on
investment (no matter who makes the investment). Second, with respect to
safety, vaccines are inherently hazardous. This http://www.naturalnews.com/vaccines.htmlis way over the top but it
gives a feel for the potential for litigation that vaccines entail; yet another
reason business enterprises usually avoid vaccine development.

What’s up for grabs?

Novartis’
and Pfizer’s applications to the FDA for fast-tracking vaccines aimed at
preventing meningitis B infections is the kind of exception that proves the
rule. Current vaccines approved in the US cover four strains of bacterial
meningitis, but not strain B. In this case, the vaccine is already available in
Canada and Europe and there is solid evidence that it is safe and good reason
to believe that it is also effective. So we have a situation in which there are
no or minimal development costs, compelling evidence that the clinical trials
will be successful, and even the expectation that FDA will fast track approval.
That isn’t the case with respect to the Ebola or West Nile vaccines.

Why
doesn’t the US government just pay for vaccine research for diseases prevalent
in the 3rd world? It does, but its budget is limited. Moreover, in
most instances vaccination programs aimed at diseases for which vaccines now
exist are far more cost effective than the development of new vaccines. “A
systematic review of the literature on the cost-effectiveness and economic
benefits of vaccines in low- and middle-income countries conducted by IVAC was
published in the December 17, 2012 issue of Vaccine. The review identified 108
relevant articles from 51 countries spanning 23 vaccines. Among the 44 articles
that reported costs per QUALY saved, vaccines cost less than or equal to $100
per QUALY in 23 articles (52%) and less than $1,000 per QUALY in 38 articles
(86%).” Ozawa et al. – http://www.ncbi.nlm.nih.gov/pubmed/23142307

Finally, even where it is not cost effective to do so, US government will pay
for vaccine research against terror threats – and Ebola has been deemed a
bioterror threat. But the government still won’t finance widespread clinical
trials because of the enormous costs. Scientists from the Vaccine Research
Center (VRC) at the National Institute of Allergy and Infectious Diseases
(NIAID) have been conducting limited human trials on Ebola vaccines since 2003 and on fast
acting vaccines since 2007. Both vaccines have been tested for safety on dozens
of volunteers without significant adverse effects (not nearly enough for FDA
approval but probably enough for military purposes) and both produce antibodies
with the appropriate markers.

Also, March 5, a Canadian firm, Tekmira Pharmaceuticals, reported
that the U.S. Food and Drug Administration had agreed to fast-track testing of
TKM-Ebola, an anti-Ebola viral therapeutic, also developed under the sponsorship
of the U.S. Department of Defense.

Are
these treatments effective in humans? (Actually, according to one report, in 2009, a researcher in
Hamburg, Germany, accidentally pricked herself with an Ebola-infected syringe. She
was treated with a vaccine brought in from Canada, which consisted of a
weakened vesicular stomatitis virus genetically engineered to contain a portion
of an Ebola virus protein that had been proven effective in monkeys. She was
subsequently observed to be asymptomatic.) It’s hard to imagine
financing the massive clinical trials that would be required to answer the effectiveness/safety
questions under normal circumstances.

Epidemics
can change this calculus. They raise the possibility of human trials in
situations where volunteers, treatment and controls, are directly exposed to
the disease, vastly reducing the needed sample size and trial time. Doctors
without Borders, which had positive results from a quick and dirty vaccine in
the Congo, has been pushing hard for permission to run clinical trials of these
vaccines in West Africa, both from NIH and the local governments in question.

So, dear colleague, the US is already pretty much doing what
you want, although maybe not exactly. Reasonable people can disagree about how
many dollars to spend and for what. But it doesn’t look to me like slavish
adherence to “the ‘free
marketplace’ that our governmental and corporate elites are so fond of” is of
more than tangential importance here. Rather, in the case of pharmaceuticals, our
regulatory apparatus is simply much more sensitive to the threats from
dangerous drugs than it is to the threats from dangerous diseases and, maybe,
that’s not an entirely bad thing. With respect to Ebola and West Nile, we have vaccines.
They will probably work on people. In a serious emergency they would almost
certainly be used.

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